Planning for Success: Navigating Regulatory Strategy and Design Verification for Combination Products

Join this webinar and engage in a conversation with the West Pharmaceutical Services team about a risk-based approach for combination products. By the end of the program, you can expect to have a better understanding of the regulatory requirements around combination product performance. Experts will guide you through the development of design inputs and help you validate physical test methods for design verification using actual devices or surrogate devices.

Register Free: https://www.pharmtech.com/pt_w/combination-products

Event Overview:

The market for injectables has experienced consistent growth over the past decade, with projections indicating continued strong expansion. This trend is largely driven by the increasing number of drug approvals each year and the flourishing biologics sector. Similarly, the combination product market has surged significantly, fueled by the growing prevalence of chronic diseases, the demand for self-administered therapies, the popularity of minimally invasive procedures, and advancements in technology. The regulatory landscape for combination product development is dynamic, with regulators now possessing substantial expertise in this area. Consequently, there is an expectation that developers of combination products must thoroughly understand both the drug and device constituents, as well as the compatibility and performance of system-critical components when these elements are combined.

This webinar will delve into the intricacies of combination products and their regulatory approval pathways. It will outline regulatory expectations for combination product submissions, emphasizing risk-based determination, evaluation, and documentation approaches for performance requirements. Once a risk-based approach is established, the session will describe the design verification strategy. Additionally, practical examples regarding developing and validating physical test methods to assess device performance will be discussed.

Key learning Objectives:

• Understand the regulatory requirements around combination product performance, which are continuing to evolve, including primary functions, essential performance, and established conditions.
• Learn how to develop design inputs and how to perform design verification.
• Explore how to validate physical test methods for design verification using actual devices or surrogate devices.

Who Should Attend:

Professionals in the areas of:

• Device development
• Regulatory
• Combination products
• Research and development (R&D)
• Quality
• Engineering
• Product development
• Technology, combination products

Speakers:

Lauren Orme, BS, PMP
Senior Director, Regulatory Policy and Intelligence
West Pharmaceutical Services

Lauren Orme, BS, PMP, has over 20 years of experience in the pharmaceutical packaging, medical device, and analytical services industries. Currently, Orme leads the regulatory affairs intelligence, human factors, and medical device labeling teams at West Pharmaceutical Services, Exton, Pennsylvania, ensuring regulatory compliance by overseeing the monitoring of global regulatory requirements, changes in regulatory trends, and implementation of compliant, validated labeling. Prior to her current role, Orme held technical roles in global analytical services and commercial to support customers with education and adoption of West’s products and services. Orme earned a bachelor of science degree in biology from West Chester University. She is certified as a project management professional.

Mike Ulman, PhD
Technology Manager, Packaging and Delivery Systems
West Pharmaceutical Services

Mike Ulman, PhD, is a technical expert with over 15 years of experience in the pharmaceutical industry. He currently serves as the technology manager for packaging and delivery systems at West Pharmaceutical Services, a position he has held for the past 3 years. In this role, Ulman spearheads the development of performance testing methodologies for combination products, ensuring their efficacy and safety.

Prior to joining West, Ulman spent 13 years at Piramal Critical Care, where he played a pivotal role in the development of process chemistry; analytical methods; extractables and leachables studies; transfer devices; and container-closure systems for fluorinated ether-based inhalation anesthetics. His professional experience also includes a 9-year tenure as a chemist at Air Products developing hydrogenation catalysts, amine-based epoxy curatives, surfactants, and fluorinated molecules.
Ulman holds a PhD degree in organometallic chemistry from the California Institute of Technology and a bachelor of science degree in chemistry from Harvey Mudd College.

Register Free: https://www.pharmtech.com/pt_w/combination-products